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Project Scope

This project team will create a users guide or White Paper with recommendations for analyses and displays associated with Hepatotoxicity, with a focus on Phase 2-4 clinical trials and integrated submission documents.



Project LeadsEmail

Melvin Munsaka (AbbVie)

melvin.munsaka@abbvie.com

Terry Walsh (Astellas Pharma)

terry.walsh@astellas.com

Katie Warren (PHUSE Project Assistant)katie@phuse.global 


Objectives & Deliverables

Timelines 

White Paper 

Q3 2022


Status
colourBlue
titleCurrent Status
Q2 Q3/3 4 2022

  • Drafted the initial scope (stage 1)Work towards releasing stage 1 of the draft white paperfor public review 



Project MembersOrganisation
Amelia PangSanofi
Charles BeasleyMSN
Darshan Bhatt Industry 
Eileen Navarro AlmarioFDA
Hongli LuMerck
John Landry Eli Lilly
John MarciankAbbVie
Patrick HannonMMS 
Paul HayashiA2 Healthcare Corporation
Preeti VenkataramanFDA
ShayamiEli Lilly
Swarnalatha ReddyIndustry
Veronical Pei YangFDA
William Palo AbbVie